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Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)

Phase 2 Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients With Acute Myeloid Leukemia (AML) With and Without FLT3-ITD Activating Mutations

NCT00989261•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Current enrollment is open only to FLT3-ITD positive, Cohort 1.
•1. Males and females age ≥18 years in second relapse or refractory.
•2. Males and females age ≥60 years in first relapse or refractory.
•3. Must have baseline bone marrow sample taken.
•4. Morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS with ≥20% bone marrow or peripheral blasts), as defined by the World Health Organization (WHO) criteria, confirmed by pathology review at treating institution.
•5. Able to swallow the liquid study drug.
•6. Eastern Cooperative Oncology Group performance status of 0 to 2
•7. In the absence of rapidly progressing disease, the interval from prior treatment to time of AC220 administration will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. The use of chemotherapeutic or antileukemic agents other than hydroxyurea is not permitted during the study with the possible exception of intrathecal (IT) therapy at the discretion of the Investigator and with the agreement of the Sponsor.
•8. Persistent chronic clinically significant non-hematological toxicities from prior treatment must be ≤Grade 1.
•9. Prior therapy with FLT3 inhibitors is permitted, except previous treatment with AC220.
+7 more criteria

Exclusion Criteria

•1. Patients over the age of 85 years except at the discretion of the Investigator and with agreement of the Sponsor.
•2. Diagnosis of acute promyelocytic leukemia
•3. Diagnosis of chronic myelogenous leukemia (CML) in blast crisis
•4. AML in relapse or refractory after 3 or more previous lines of chemotherapy (and/or HSCT) treatment
•5. AML or antecedent MDS secondary to prior chemotherapy
•6. Persistent clinically significant non-hematological toxicity that is Grade \>1 by NCI CTCAE v4 from prior chemotherapy
•7. Patients who have had HSCT and are within 100 days of transplant and/or are still taking immunosuppressive drugs and/or have clinically significant graft-versus-host disease requiring treatment and/or have \>Grade 1 persistent non hematological toxicity related to the transplant
•8. Clinically active central nervous system (CNS) leukemia. Patients with CNS leukemia, which is controlled, but who are still receiving IT therapy at study entry may be considered eligible and continue receive IT therapy at the discretion of the Investigator and with agreement of the Sponsor.
•9. Patients who have previously received AC220
•10. Disseminated intravascular coagulation (DIC) (diagnosis by laboratory or clinical assessment)
+10 more criteria

Locations (85)

University of California, San Francisco

San Francisco, California, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

November 1, 2009

Primary Completion Date

September 28, 2012

Completion Date

December 31, 2014

Last Updated

December 11, 2019

Enrollment

333

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

Compound AC220

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)

Inclusion Criteria

Exclusion Criteria

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